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NCT01705691 · ClinicalTrials.gov registry record · Phase 2
Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer
A Phase 2 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01705691: Completed Phase 2 study, sponsored by NSABP Foundation.
NCT01705691 is a Phase 2 study that has completed, run by NSABP Foundation. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01705691, a Phase 2 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary aim of the study is to determine the pathologic complete response (ypCR) in breast and axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant regimens.
Primary Outcome
Percentage of patients with no histologic evidence of cancer in breast and axillary lymph nodes.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Eribulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT01705691 record still lists
NCT01705691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01705691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01705691 about?
NCT01705691 is a clinical study titled "Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer". NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive n...
What is the current status of trial NCT01705691?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-09. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01705691?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Eribulin (DRUG).
Who is sponsoring clinical trial NCT01705691?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01705691's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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